The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant. Currently, the standard way of giving radiation is with "3D radiation", which only uses 2-5 beams of radiation. "Multi-beam" IMRT works by using 8-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is to reduce complications after irradiation to the implants.

The study doctors have recently completed a trial using this technique and are now specifically looking at its impact on women with implant reconstructions who are undergoing post-mastectomy radiation therapy. By delivering a more "customized" dose of radiation to the implant, the intent is to reduce side effects of radiation on the implant.

The treatment would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2).

The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.

Detailed Description:

Patients will undergo mastectomy + axillary dissection with immediate tissue expander placement. As is the current practice at our institution, patients who receive adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month after chemotherapy and radiation to begin approximately one month after exchange. Patients who receive neoadjuvant chemotherapy will undergo "rapid expansion" of the expander and begin radiation at least 4 weeks following surgery, although it may be performed sooner if the patient has recovered from surgery and the treating physician deems it safe to proceed with treatment. In these patients, exchange for the permanent implant will occur no sooner than 6 months ± 2 weeks following radiation.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Female age ≥ 18 years of age with a life expectancy estimated to be at least 2 years

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086578